Fish Oil for HIV-Related Inflamm-aging and Immune Senescence
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|ClinicalTrials.gov Identifier: NCT02102724|
Recruitment Status : Completed
First Posted : April 3, 2014
Results First Posted : March 26, 2019
Last Update Posted : March 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|HIV Infection||Dietary Supplement: Fish oil that contains omega-3 fatty acids Dietary Supplement: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
Participants were randomized to one of two arms:
Intervention arm = fish oil Control arm = placebo.
|Masking:||Double (Participant, Investigator)|
|Masking Description:||All gelcaps were overencapsulated to mask their contents|
|Official Title:||Fish Oil for HIV-Related Inflamm-aging and Immune Senescence|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
Experimental: Fish Oil
Participants will receive fish oil gelcaps that contain 1.6 grams of omega-3 fatty acids (800 mg of EPA, 600 mg DHA, 200 mg other omega-3 fatty acids) for 12 weeks.
Dietary Supplement: Fish oil that contains omega-3 fatty acids
Fish oil gelcaps that contain 800 mg of EPA, 600 mg of DHA, 200 mg other omega-3 fatty acids
Other Name: Carlson Brand fish oil
Placebo Comparator: Placebo
Participants will receive 1 gram of oleic sunflower oil for 12 weeks.
Dietary Supplement: Placebo
Gelcaps that contain 1 gram of oleic sunflower oil
- Change in Markers of Immune Senescence Between Baseline Values and Values After 12 Weeks of Supplementation [ Time Frame: End of 12-Week Supplementation Period ]Markers of immune senescence will include change in the expression of the senescence markers CD28 and CD57 on the surface of peripheral CD4+ and CD8+ T lymphocytes. We will measure the percentage of CD4+ and CD8+ T lymphocytes that are CD28-/CD57- or CD28-/CD57+. We will subtract the percentage obtained at Week 12 from the baseline percentage to calculate the change scores.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02102724
|United States, Illinois|
|Rush University Medical Center|
|Chicago, Illinois, United States, 60612|
|Principal Investigator:||Barbara A. Swanson, PhD, RN||Rush University College of Nursing|